Hurting People while Trying to Help?

A piece in this week’s Nature reports that a large vaccine trial for HPV, which can cause cervical cancer, is in trouble in India due to serious violations of ethical rules and informed consent. The trial, which was hoping to assess the acceptance of the vaccine and the cost of administering the vaccine in different parts of the country, apparently had headmasters of the girls’ schools signing consent forms in addition to other violations. Can you imagine someone sticking a needle in your teenage daughter’s arm without your or, if she is old enough, her own informed consent? According to the director of the vaccine project “…All necessary ethical approvals were there; the problem was how different individuals or teams implemented it."

This does not seem to be an isolated incident. This paper by Angotti et al. (2010) reports that women seeking antenatal care in Malawi feel that HIV testing is compulsory in order to receive proper care, even though the guidelines for the policy of routine HIV testing to prevent mother-to-child transmission is clear at the national level, adhering to WHO/UNAIDS guidelines: it is an opt-out policy with informed consent, i.e. full information and then a voluntary decision by the female patient. The problem seems to be that the nurses and other staff at these clinics often do not obtain proper informed consent. However, it is not clear from the paper how much of the problem is due to implementation problems, as in India, vs. a mistaken perception by the women visiting these clinics.

In both cases, there are real and detrimental consequences for public health, in addition to the ethical violations: in India, the acceptance of the vaccine may be in jeopardy as a result of the scandal even though it seems to be safe and may prevent many cases of cervical cancer in India as it does in developed countries. In Malawi, women (sometimes also due to their husbands’ insistence) stop going to these clinics and deliver at home with traditional birth attendants, increasing the likelihood of complications taking the mother’s or the baby’s life. The problem in each case seems to be that, despite guidelines that seem clear (to educated people who wrote them) at the national level, what happens on the ground deviates significantly.

Why might implementers act differently on the ground? Setting hard-core violations aside (apparently participants were selected from vulnerable tribal populations in India), it is possible that the work load of the nurses is too high to take the time to properly explain their patients the voluntary nature of testing, put them at ease, build trust, etc. It is also possible that the nurses, who are more educated and better-off than their average clients, are being paternalistic, believing that they are acting in the best interest of their clients and their babies: it is possible that many mothers may refuse HIV testing for their own reasons, including pressure from their husbands.

It is also possible that informed consent is a problematic issue in these types of settings. A colleague of mine says that she always thought that the script included in informed consent documents of study protocols just sound too formal. Enumerators, counselors, et al. are supposed to stick to these scripts, which, they may believe, are not appropriate for the task at hand. Furthermore, when there is a serious inequality of power between the provider and the client, it is not clear that a two-minute recitation of some protocol can put the client at ease: the client is there because she needs a service (or, in the case of many studies, she is part of an intervention arm that will provide her with something that will improve her welfare). The safe thing for her to do is to go along with whatever she thinks the provider wants her to do, even though it is properly explained to her that her decision will not affect the care she receives (or her treatment status). Freedom of choice is difficult when you’re poor and uneducated.

In some cases, even researchers feel the need to do away with informed consent. Van den Borne (2007) describes her use of “mystery clients” in a study of bar girls in Malawi. Wanting to study the behavior of bar girls when their clients did not want to use a condom, she was told by one bar owner that there was no way the girls would talk to her honestly if she revealed her status as a researcher and wanted to interview them with their consent: they might think she is from the police, or the Ministry of Health, they might lie to her, etc. Van den Borne decided to employ “fake Johns,” men who would strike up a conversation with these girls, buy them beer and food, carry on a negotiation about having sex without condoms, but then would stop before engaging in sexual activity with the girl (per the study protocol, a distraction was supposed to happen, such as a friend calling, etc. that required him to leave. The men, i.e. the enumerators, were strictly instructed to not engage in sexual activity and were not allowed to use tape recorders.)

When van den Borne went to a western IRB (AIDS Task Force of EC in Brussels), they were nervous about the lack of informed consent and feared a possible scandal (This, it seems to me, is usually the attitude of the institutions providing ethical clearance: to cover themselves and avoid scandals while allowing their researchers to do what they want to do, rather than a genuine concern about the well-being of the participants). However, they allowed her to proceed if she could obtain a local IRB approval.

In Malawi, the board was actually much more sympathetic and commanded her for her innovative method for research that could eventually help these same bar girls. They agreed with the assessment of the bar owner, but were also worried about the value of the time the bar girls would waste with the “fake Johns.” They suggested that she find a way to compensate the women for their lost earnings, which resulted in van den Borne increasing the entertainment allowance by about 33 cents (towards food and beverage).

Van den Borne’s story above shows the possibility for a vast difference between the approaches of IRBs in developed vs. developing countries: the concerns can be completely different. However, mystery clients are not unknown to researchers in developed countries, either. The story of fruit salad and chocolate cake Jed wrote about last week, had to have mystery clients in the form of the people offering the food along the way. I was once told by a psychologist about a similar study assessing the behavior of Asian American men: instead of being offered food, the subjects were bumped by a rude man, who told them to watch where they were going and went on to use an ethnic slur. The researchers then assessed how upset the participants were and whether there were any differences between older and younger men (the idea, by the way, was that older men would be less sensitive to the use of a word that they heard a lot more while growing up than the younger men, who would get angrier).

When I expressed my disbelief (this was a few years ago) that ethical approval was given to this protocol, the colleague said that the board had simply weighed the harm to the participants against the expected value of the research. I heard similar arguments about studies that collected blood samples to test for diseases in laboratories, but did not return to inform the participants of their statuses, citing the high monetary cost of traveling back to physically visit each participant in sometimes remote villages in these developing countries. Ugh… In the end, at least some of these boards seem to have managed to make this process akin to one that is very familiar to us economists: a cost-benefit analysis weighing the trade-offs. It is not very surprising that implementation of protocols on the ground ends up being quite different than what the higher-ups in the capital city intended.

What we need is the meaningful participation of people, the poor, the marginalized, and the uneducated, in the efforts for development – whether it is a decision to get tested for HIV or to allow their children to get vaccinated. However, inducing participation from such populations is not easy: the existing inequalities of opportunity, wealth, and power, as well as discrimination mean that efforts to do so cannot be rushed – certainly not within the study and project cycles that we are used to. My colleagues Ghazala Mansuri and Vijayendra Rao have written an excellent book called “Localizing Development: Does Participation Work,” at which I got a sneak peak as a peer reviewer. Look for it in your bookstores later this year: it will likely change your approach to “inducing participation.” And, without meaningful participation, no amount of carefully written scripts in Washington, DC, New Delhi, or Lilongwe will lead to truly “informed consent.”